T/SHPPA 023-2023 Active

Scope: This document stipulates the design and implementation requirements for long-term follow-up clinical studies of autologous CAR-T cell therapy products for marketing authorization holders and related parties. It applies to the management of long-term follow-up clinical studies of such products after they are put on the market, and can also serve as a reference for the implementation of long-term follow-up clinical studies during the R&D and registration declaration phases of such products. Main technical content: The main purpose of long-term follow-up of CAR-T cell therapy products is to collect patients' delayed adverse reactions, understand the persistence of the product in the body, and observe the changes in efficacy over time, so as to identify and reduce the long-term risks of patients receiving CAR-T cell therapy products, and help evaluate the benefit-risk situation of the product. This document provides technical guidance for long-term follow-up clinical studies of autologous CAR-T cell therapy products from aspects such as considerations and the design and implementation of long-term follow-up studies, ensuring the timely collection of signals of delayed adverse reactions and the identification and reduction of such risks.